GORE? EXCLUDER? Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
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StatusAccepting Candidates
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Age21 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
Description
The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy.
This clinical study will include up to fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.
Details
Full study title | Assessment of the GORE? EXCLUDER? Conformable AAA Endoprosthesis (CEXC Device) in the Treatment of Abdominal Aortic Aneurysms |
Protocol number | OCR20218 |
ClinicalTrials.gov ID | NCT02489539 |
Phase | N/A |
Eligibility
Inclusion Criteria:
AAA meeting any of the following criteria:
Maximum diameter ≥50 mm
Rapid growth (>5 mm in a 6 month period)
Non-ruptured AAA presenting with clinical symptoms
Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis,
Including:
Adequate iliac / femoral access
Infrarenal aortic neck diameter 16-32 mm
Infrarenal aortic neck length ≥10 mm
Aortic neck angle ≤ 90˚
Distal iliac artery seal zone ≥10 mm
Iliac artery diameter 8-25 mm
An Informed Consent Form (ICF) signed by Subject
Male or infertile female
Able to comply with Protocol requirements including following-up
Life expectancy > 2 years
Age ≥ 21 years
Exclusion Criteria:
Mycotic or ruptured aneurysm
Known concomitant thoracic aortic aneurysm which requires surgical intervention
Renal insufficiency defined as creatinine > 2. 5 mg/dL or patient undergoing dialysis
New York Heart Association (NYHA) class IV
Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
Severely tortuous or stenotic iliac and / or femoral arteries
Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
Participating in another investigational device or drug study within 1 year of treatment
Systemic infection which may increase the risk of endovascular graft infection
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
Planned concomitant surgical procedure or major surgery within 30 days of treatment
date
Known history of drug abuse
Known sensitivities or allergies to the device materials
Lead researcher
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Martin R Back, MD, FACS, RPVIVascular Surgeon
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Martin Back -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.